The present invention relates to a device for protecting a cover, to the use of a device for protecting a cover, to a method of fitting a cover on a probe, and to a method of making a device for protecting a cover.
Patent FR-A-2 695 999=U.S. Pat No. 5,479,928 describes an intracorporeal probe for accurately determining the speed of a liquid medium, and in particular blood flow rate in the aorta. Other intracorporeal probes are known in the medical field for humans and for animals.
Such a probe must be subjected to a sterilization operation prior to be used on a patient. Such sterilization is lengthy, expensive, and difficult to implement. It is necessary to apply sterilization agents which are expensive, and in particular pharmaceuticals, conscientiously to the probe. Care must be taken of the probe while it is being handled in this way since such a probe is fragile and the sterilization agents can be harmful. In addition, it is necessary to renew the sterilization operation on each occasion that the probe is used, thereby increasing the risk of damaging the probe.
It is also possible to use a cover to protect the patient from the transmission of pathogens when such a probe is used. However, such a cover is not easy to fit onto the probe, and in addition care must be taken to ensure that the cover is sterile.
The invention seeks to resolve these problems by proposing a device for protecting a cover that enables the cover to be fitted easily on the probe and that guarantees that the cover is sterile. Thus, the invention guarantees hygiene for the patient during use of the probe without it being necessary to sterilize the probe on each use. The invention thus proposes a solution which is simple, low cost, and easy to implement.
The invention also provides the use of a device for protecting a cover, a method of fitting a cover on a probe, and a method of making a device for protecting a cover.
The device of the invention for protecting a cover can advantageously be employed when using the probe known under the name xe2x80x9cDYNEMO 3000xe2x80x9d, produced by SOMETEC.
More precisely, the invention provides a device for protecting a cover, the device comprising a hollow tubular protective element which is open at both ends, referred to as a protective tube, at least a portion of said cover being placed inside the tube, the cover being flexible and in the form of a tube that is closed at one end and open at its other end.
Such a device makes it possible to use a probe without it being necessary to sterilize said probe. In addition, the cover that is used is easy to fit and to handle.
Preferably, the device has means facilitating insertion of the cover inside the protective tube.
Advantageously, the means for facilitating insertion comprise a flexible coupling mounted on that one of the open ends of the protective tube which is adjacent to the closed end of the cover, specifically so as to enable temporary suction to be established in this region.
Preferably, the protective tube has a plurality of means enabling localized regions to be established in which the cover is not in contact with the inside wall of the protective tube, and in particular internal ridges preferably disposed substantially parallel to the longitudinal axis of the protective tube.
Advantageously, the ridges are continuous, extending substantially from one end to the other of the protective tube, thereby making it possible, for example, to establish temporary suction between the cover and the inside wall of the tube.
Preferably, the cover is flexible and is folded back over the protective tube at its end remote from the closed end of the cover.
Advantageously, the device is made in such a way that the protective tube has an inside wall, and the protective tube has means for holding the cover substantially against the inside wall of the protective tube, e.g. means comprising a rod of appropriate diameter.
Preferably, the cover contains an impedance-matching medium, and in particular a gel, for matching impedance between the cover itself and a measuring element for insertion at least temporarily inside the flexible cover.
Advantageously, said impedance-matching medium is an acoustic impedance-matching medium, thus enabling soundwaves to be transmitted substantially without disturbance.
Preferably, said impedance-matching medium is disposed substantially at the closed end of the cover, said impedance-matching medium, such as a gel, preferably being biocompatible, and better still being edible.
Advantageously, the device is sterilized, in particular packaged in a sterilizable sealed package which is advantageously transparent, at least in part.
Preferably, the cover is of a length that is sufficient to cover the outside surface of an intracorporeal probe, preferably an intracorporeal probe having an ultrasound type measuring element, e.g. for measuring the speed or flow rate of a flowing body fluid, such as blood.
Advantageously, the cover is made of a sterilizable flexible material such as silicone or a natural or synthetic rubber such as SEBS.
The invention also provides the use of a device of the kind described in the medical field in particular for covering, preferably in sterile manner, a tool that is to be inserted in an animal or a human being, in particular in a natural passage such as the esophagus, the urethra, the rectum, or a blood vessel.
The invention also provides a method of fitting a cover on a probe, the cover having one opening and being contained at least in part inside a tube, a device of the kind described being provided, said method comprising the following steps:
the protective tube is coupled to a vacuum pump;
a vacuum is established inside the tube adjacent to the closed end of the cover within a closed space as defined between the cover, the vacuum pump, and the protective element;
the rod is withdrawn while the vacuum is maintained;
the probe is inserted into the cover;
the vacuum is eliminated; and
the assembly comprising the probe with the cover mounted thereon is withdrawn.
The invention also provides a method of making a device of the kind described, in which method:
the cover is prepared by cutting a portion of flexible tube from a reel on which the tube is wound, which portion serves to constitute the cover, and by sealing one end of the portion by means of a hot press;
the cover is inserted in the tube by means of a rod, and a few millimeters of the cover is folded back over the tube;
a predetermined quantity of an impedance-matching medium is inserted inside the cover, and then the plug rod is inserted into the cover; and
the device prepared in this way and accompanied by a cutting tool is packaged individually.
Advantageously, suction is established outside the cover prior to inserting the impedance-matching medium and the plug rod into the cover, after which the suction is eliminated.